Sleep ApneaPhase 4NCT02426424
Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
A Phase 4 study testing Watchpat and CPAP in people with Sleep Apnea and Stroke, run by Soroka University Medical Center.
Trial summary
This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Stroke
- What is being tested?
- Watchpat and CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Dec 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18.
- Admitted to the Neurology Department due to acute ischemic stroke.
- Able to sign informed consent.
- Admission NIHSS 6-12.
Who cannot join
- Stroke symptom onset more than 72 hours prior to the enrollment
- Transient Ischemic Attack.
- Chronic pulmonary disease requiring home oxygen treatment.
- History of C-PAP treatment
About this study
This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.
The study will enroll 140 subjects which will be randomized into one of two arms:
- Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
- Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
Read the detailed description
Patients eligible to be enrolled in this study are patients admitted to the Department of Neurology due to acute ischemic stroke up to 72 hours from the start of the stroke symptoms.
After receiving written informed consent from the patient, patients will be randomized into the intervention and control groups (1:1). The intervention group will be tested for sleep apnea and C-PAP treatment will be initiated during the initial hospitalization. The control group will receive standard medical care. Control group patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
All subjects:
- At the baseline, physical examination MRS and NIHSS will be performed by the neurologist.
- Sleep testing at the baseline with mobile sleep lab device (Watch PAT)
- Four questionnaires will be administered for all patients: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), quality of life (SF36), depression scale (Beck).
- Blood sample will be taken for CRP, TNF-alpha, IL-6 and IL1 beta, VEGF, HBA1C, LDL and markers of endothelial dysfunction. These blood tests will be repeated at 3 and 6 months.
- At discharge from the Neurology Department, 3 months and 6 months all patients will undergo NIHSS assessment.
- Patients will be referred to the Soroka stroke clinic with rehabilitation program.
- All patients will undergo 3 brain MRI scans, at baseline hospitalization, 3 and 6 months after.
Intervention group:
- In the intervention group, the mobile sleep lab device (Watch PAT) will be used to identify patients with sleep apnea.
- Treatment phase: Patients with (apnea hypopnea index) AHI≥15 will receive an in-hospital treatment with CPAP and continue CPAP treatment following discharge. The CPAP parameters will be titrated during the hospital stay.
Control group:
- Patients will receive standard medical care. At three months, patients will undergo home sleep test with Watch-PAT device.
- Patients with (apnea hypopnea index) AHI≥15 will receive CPAP treatment with titration at home.
TRIAL PROCEDURES 1. Patients eligible to be enrolled in this study are patients admitted to the Neurology Department due to stroke up to 72 hours after the showing of stroke symptoms.
- At the baseline, physical examination, MRS and NIHSS will be performed by one of the Neurology Department doctors.
- After receiving written informed consent from the patient, patients will be divided into 2 groups. Study group will have detection and treatment in 72 hours after stroke. Control group will have detection and treatment 3 months after stroke.
STUDY AND CONTROL GROUP
- The patient will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
- Next, the mobile sleep lab device (Watch PAT) will be placed on the patient's finger which will provide the apnea-hypopnea Index (AHI) and respiratory disturbance index (RDI).
- Blood samples for circulating inflammatory biomarkers and endothelial dysfunction will be performed in the morning. Four tubes of peripheral venous blood will be drawn. Every study patient will be tested for the presence of pro-inflammatory state. Specifically, the investigators will measure the presence of high sensitive C Reactive Protein (CRP) and centrifuged sera will be tested (by ultra- sensitive ELISA), for levels of circulating TNF-alpha, IL-6 and IL1 beta. Sera will also be tested for vascular endothelial growth factor (VEGF) and markers of endothelial dysfunction; P-selectin. LDL, HBA1C.
- At discharge from the Neurology Department, the patient will undergo NIHSS assessment.
- Half of patients randomly chosen will be asked to join an "early treatment" group for 6 months of C-PAP treatment. Patients from the other half will be asked for C-PAP treatment at 3 months (late intervention).
- All four questionnaires will be completed by all patients at the end of the follow up period.
- MRI scan will be done at three points: CVA admission, 3 and 6 months after.
- Six months after baseline hospitalization, patients from both groups will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
- Conditions
- Sleep Apnea, Stroke
- Being tested
- Watchpat, CPAP
- Keywords
- c-PAP
- Medical subject headings
- Sleep Apnea Syndromes, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WatchpatDevice
WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.
CPAPDevice
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.
| Study group | Role | What they receive |
|---|---|---|
| Investigatory 1 | Experimental | The sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months. Receives: Device: Watchpat; Device: CPAP |
| Investigatory 2 | Experimental | The sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months. Receives: Device: Watchpat; Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
NIHSS change from the baseline to 3 months
Change in the NIHSS score from admission to three months
Measured: 3 months
Secondary outcomes (10)
NIHSS change score from admission to discharge from the Neurology Department.
Measured: 3 months
NIHSS score change from admission to 6 months following hospitalization
Measured: 6 months
NIHSS score change from three to six months following hospitalization
Measured: 6 month
Prevent recurrent strokes at 6 months
Measured: 6 months
Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)
Measured: 6 months
Evaluate new MRI ischemic lesions between 3 MRI scans.
Measured: 6 months
Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline
Measured: 6 months
Change quality of life (SF36) at 3 and 6 months from the baseline
Measured: 6 months
Change depression scale (Beck) at 3 and 6 months from the baseline
Measured: 6 months
Change number of severe adverse events (SAE) at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startJan 2018 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Failure to have funding to perform the trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gal Ifergane MD, Soroka University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02426424
- Sponsor's protocol ID
- SOR-0305-14-ctil
- Status last verified
- Apr 2018
- First submitted
- 24 Dec 2014
- Last updated
- 19 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Early C-PAP Treatment For Sleep Apnea On Rehabilitation Of Stroke Patients
- ClinicalTrials.gov ID
- NCT02426424
- Acronym / sponsor ID
- SOR-0305-14-ctil
- Conditions
- Sleep Apnea, Stroke
- Keywords
- c-PAP
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Failure to have funding to perform the trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 27 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective randomized open label trial with control-to-treatment cross-over. The investigators wish to assess the effectiveness and safety of immediate detection and treatment for Sleep Apnea in Stroke patients. The investigators hypothesize that in patients with acute ischemic stroke a sleep apnea treatment by CPAP will result in a better neurological outcome and more successful rehabilitation.
The study will enroll 140 subjects which will be randomized into one of two arms:
- Investigational - The sleep study will be performed during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge.
- Control group -Will receive standard medical care. Patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
Detailed description
Patients eligible to be enrolled in this study are patients admitted to the Department of Neurology due to acute ischemic stroke up to 72 hours from the start of the stroke symptoms.
After receiving written informed consent from the patient, patients will be randomized into the intervention and control groups (1:1). The intervention group will be tested for sleep apnea and C-PAP treatment will be initiated during the initial hospitalization. The control group will receive standard medical care. Control group patients will undergo sleep study at 3 months following discharge and patients diagnosed with sleep apnea will be treated with C-PAP.
All subjects:
- At the baseline, physical examination MRS and NIHSS will be performed by the neurologist.
- Sleep testing at the baseline with mobile sleep lab device (Watch PAT)
- Four questionnaires will be administered for all patients: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), quality of life (SF36), depression scale (Beck).
- Blood sample will be taken for CRP, TNF-alpha, IL-6 and IL1 beta, VEGF, HBA1C, LDL and markers of endothelial dysfunction. These blood tests will be repeated at 3 and 6 months.
- At discharge from the Neurology Department, 3 months and 6 months all patients will undergo NIHSS assessment.
- Patients will be referred to the Soroka stroke clinic with rehabilitation program.
- All patients will undergo 3 brain MRI scans, at baseline hospitalization, 3 and 6 months after.
Intervention group:
- In the intervention group, the mobile sleep lab device (Watch PAT) will be used to identify patients with sleep apnea.
- Treatment phase: Patients with (apnea hypopnea index) AHI≥15 will receive an in-hospital treatment with CPAP and continue CPAP treatment following discharge. The CPAP parameters will be titrated during the hospital stay.
Control group:
- Patients will receive standard medical care. At three months, patients will undergo home sleep test with Watch-PAT device.
- Patients with (apnea hypopnea index) AHI≥15 will receive CPAP treatment with titration at home.
TRIAL PROCEDURES 1. Patients eligible to be enrolled in this study are patients admitted to the Neurology Department due to stroke up to 72 hours after the showing of stroke symptoms.
- At the baseline, physical examination, MRS and NIHSS will be performed by one of the Neurology Department doctors.
- After receiving written informed consent from the patient, patients will be divided into 2 groups. Study group will have detection and treatment in 72 hours after stroke. Control group will have detection and treatment 3 months after stroke.
STUDY AND CONTROL GROUP
- The patient will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
- Next, the mobile sleep lab device (Watch PAT) will be placed on the patient's finger which will provide the apnea-hypopnea Index (AHI) and respiratory disturbance index (RDI).
- Blood samples for circulating inflammatory biomarkers and endothelial dysfunction will be performed in the morning. Four tubes of peripheral venous blood will be drawn. Every study patient will be tested for the presence of pro-inflammatory state. Specifically, the investigators will measure the presence of high sensitive C Reactive Protein (CRP) and centrifuged sera will be tested (by ultra- sensitive ELISA), for levels of circulating TNF-alpha, IL-6 and IL1 beta. Sera will also be tested for vascular endothelial growth factor (VEGF) and markers of endothelial dysfunction; P-selectin. LDL, HBA1C.
- At discharge from the Neurology Department, the patient will undergo NIHSS assessment.
- Half of patients randomly chosen will be asked to join an "early treatment" group for 6 months of C-PAP treatment. Patients from the other half will be asked for C-PAP treatment at 3 months (late intervention).
- All four questionnaires will be completed by all patients at the end of the follow up period.
- MRI scan will be done at three points: CVA admission, 3 and 6 months after.
- Six months after baseline hospitalization, patients from both groups will answer four questionnaires: Epworth Sleepiness Scale (ESS), Pittsburgh Sleep Quality Index (PSQI), "quality of life" (SF36) and "depression scale" (beck).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigatory 1 | Experimental | Device: Watchpat, Device: CPAPThe sleep study will be performed via Watchpat during the index hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP both during the hospital stay and after discharge for three months. |
| Investigatory 2 | Experimental | Device: Watchpat, Device: CPAPThe sleep study will be performed via Watchpat at home three months after hospitalization with acute stroke. Following the diagnosis of sleep apnea, patients will be treated with C-PAP for three months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients over the age of 18.
- Admitted to the Neurology Department due to acute ischemic stroke.
- Able to sign informed consent.
- Admission NIHSS 6-12.
Key exclusion criteria (4 listed)
- Stroke symptom onset more than 72 hours prior to the enrollment
- Transient Ischemic Attack.
- Chronic pulmonary disease requiring home oxygen treatment.
- History of C-PAP treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WatchpatWatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea. | Device | Investigatory 1, Investigatory 2 |
| CPAPContinuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own. | Device | Investigatory 1, Investigatory 2 |
Primary outcome
NIHSS change from the baseline to 3 months
Time frame: 3 months
Change in the NIHSS score from admission to three months
10 secondary outcomes
NIHSS change score from admission to discharge from the Neurology Department.
Time frame: 3 months
NIHSS score change from admission to 6 months following hospitalization
Time frame: 6 months
NIHSS score change from three to six months following hospitalization
Time frame: 6 month
Prevent recurrent strokes at 6 months
Time frame: 6 months
Analyse the composite of cardiovascular events at 6 months (acute myocardial infarction, coronary revascularization, death or recurrent stroke)
Time frame: 6 months
Evaluate new MRI ischemic lesions between 3 MRI scans.
Time frame: 6 months
Change Epworth Sleepiness Scale (ESS) at 3 and 6 months from the baseline
Time frame: 6 months
Change quality of life (SF36) at 3 and 6 months from the baseline
Time frame: 6 months
Change depression scale (Beck) at 3 and 6 months from the baseline
Time frame: 6 months
Change number of severe adverse events (SAE) at 3 months
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Watchpat and CPAP in people with Sleep Apnea and Stroke, run by Soroka University Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NIHSS change from the baseline to 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2018.